117. IND Safety Reports (§312.32)

Sponsor Requirements for IND Safety Reports

Sponsors must promptly review all information received or identified that is relevant to the safety of "their" investigational drugs. Via IND Safety Reports, sponsors must immediately notify FDA and all participating investigators of potential serious risks from clinical trials or any other sources.

Investigator Requirements for IND Safety Reports

Although sponsors commonly instruct investigators to submit IND Safety Reports to the IRB, the IRB is only required to review possible "unanticipated problems involving risks to subjects or others: (AKA: unanticipated problem). Not all findings in IND Safety Reports meet the definition for unanticipated problem.

Investigators must review IND Safety Reports sent by the sponsor and should promptly submit the report to the IRB under the following circumstances:

  • The Report meets the definition for unanticipated problem.
  • The Report results in sponsor-required changes to the research protocol, investigator brochure, consent form, or other aspects of the clinical investigation.
  • The sponsor indicates the Report involves safety information that must be reviewed by the IRB to determine either of the following apply:

o   a change in research is required or

o   currently enrolled subjects should be informed of the new information.

IRB Review of IND Safety Reports

The QI Officer will promptly review all IND Reports submitted by investigators. Those involving an unanticipated problem will be reviewed by the IRB according to IRB policy.

Those in which the sponsor requests changes or IRB review (i.e., the second and third bullets in the list above) will be forwarded to the IRB Chair or RIO director for assessment, or assigned to the next convened meeting of the IRB.

Reports not involving any of the circumstances noted above \may be acknowledged by the IRB.

If the sponsor requires that investigators submit all IND Safety Reports to the IRB, including those not necessarily requiring IRB review, the Reports may be submitted in bulk at continuing review.

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